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Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease

Sponsor
Sandoz (Industry)
Overall Status
Completed
CT.gov ID
NCT01673724
Collaborator
(none)
121
Enrollment
7
Locations
2
Arms
51.7
Duration (Months)
17.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether pramipexole and bromocriptine are effective in the treatment of non-motor symptoms in Parkinson's Disease.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

PRIMARY OBJECTIVE Evaluate the Improvement of Nonmotor symptom scale (NMSS) between Pramipexole and Bromocriptine for early Parkinson's disease during 24-week treatment

SECONDARY OBJECTIVE

  • Evaluate the improvement for Depression which is one of the Nonmotor symptoms

  • Evaluate the improvement of clinical symptoms between two groups

  • Evaluate the improvement of Quality of Life between two groups

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized Study
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
May 23, 2016
Actual Study Completion Date :
May 23, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: pramipexole

dosage form: tablet dosage: pramipexole 0.125/0.25/0.5/1mg frequency: tid duration: 24weeks

Drug: pramipexole
pramipexole
Other Names:
  • Sandoz Pramipexole

    		•
    Active Comparator: Bromocriptine

    bromocriptine dosage form: white round tablet

    Drug: Bromocriptine
    bromocriptine
    Other Names:
  • Parlodel tab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. K-NMSS [24 weeks]

      Evaluate The total and each category score of K-NMSS

    Secondary Outcome Measures

    1. K-MADRS [24 weeks]

      Evaluate the Improvement of the depression refering to the total score of K-MADRS

    2. UPDRS I/II/III [24 weeks]

      Evaluate the improvement of UPDRS I/II/III

    3. K-PDQ39 [24 weeks]

      Evaluate the improvement of Patient's QOL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Parkinson's disease patients in accordance with UK Queensquare Brain Bank

    • modified Hoehn & Yahr stage <3

    • Dopamine agents(Levodopa, dopamine agonists) naive patients, or the patients who have discontinued the agents at least four weeks before the screening in case of using the dopamine agents are administered before.

    Exclusion Criteria:

    • K-MMSE<24

    • History of drug-induced Parkinsonism

    • secondary parkinsonism

    • History of schizophrenia or hallucination

    • Requirement of treatment with anti-depressants due to depressive disorder

    • Pregnant and/or breeding women

    • Renal inadequacy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Ansan Hospital Ansan Korea, Republic of
    2 Inje University Busan Paik Hospital Busan Korea, Republic of
    3 Youngnam University Hospital Daegu Korea, Republic of
    4 Kangwon Nat'l University Hospital Kangwon Korea, Republic of
    5 Inje university Sanggye Paik Hospital Seoul Korea, Republic of
    6 Korea University Anam Hospital Seoul Korea, Republic of
    7 Korea University Guro Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Sandoz

    Investigators

    • Principal Investigator: Seongbeom Koh, MD, Korea University Guro Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sandoz
    ClinicalTrials.gov Identifier:
    NCT01673724
    Other Study ID Numbers:
    • SKL001
    First Posted:
    Aug 28, 2012
    Last Update Posted:
    Sep 15, 2017
    Last Verified:
    Sep 1, 2017
    Additional relevant MeSH terms:
    Parkinson Disease
    Pramipexole
    Bromocriptine

    Study Results

    No Results Posted as of Sep 15, 2017